It is our mission to secure Indiana’s position as a global leader in life sciences by advocating, connecting, promoting, and delivering tangible benefits on behalf of our diverse corporate members.

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The Indiana Health Industry Forum is becoming the Indiana Life Sciences Association!

Be on the lookout for our new branding, website, and contact information. We will be rolling out the new brand starting with the logo reveal on October 9th and will be sure to keep our members and friends updated on our progress! Thank you all for your support over the past 30 years!

Don't Miss This Member Benefit!!

Access to capital is the #1 issue we hear from our members, so we are offering you a NEW member-only service to help you access non-dilutive funding from the government. By teaming up with G2G Consulting, which has secured over $528 million in government funding since 2007, you will receive a monthly report on life sciences grants and a monthly webinar with government funding experts to ask questions and gain insights on how to obtain funding. This Government Biosciences Grant Report or GBG Report is updated and published monthly with all life sciences opportunities spanning from NIH to BARDA to DoD to USDA to NSF to ARPA-H included.

Learn More

Not an IHIF Member? Sign up here to access this benefit and more!

Life Science Executives,

On Demand

BiotechExec provides life science companies with the strategic business solutions and talent needed to bring their life-changing, life-saving products to the market.

TIP: Will your company be participating in trade shows or partnering events this year? Investors and strategics generally accept meetings with people they know before they take meetings with people they don’t know.  Consider adding an experienced Business Development exec from BiotechExec with their established contacts and industry relationships. Leveraging their network can help your company get broad visibility and establish meaningful connections, to optimize the event experience and investment in time and cost.

Learn More! Contact: Steve Joseph, VP Business Development, Biotech Exec

https://biotechexec.com/

News From Around the Industry

Lilly to invest another $4.5B in Lebanon site for new ‘medicine foundry’

The funding for an advanced manufacturing and drug development center will bring the Indianapolis-based drugmaker's total investment in the Boone County site to more than $13 billion and add to its employee count there.

More

Now Open: Free Program for Entrepreneurship Training and SBIR/STTR Application Assistance

NCI SBIR/STTR Training and Entrepreneurship Program (STEP) Informational Webinar

Tuesday, October 8, 2024 2:00 PM - 3:00 PM

(UTC-04:00) Indiana (East)

Are you looking to kickstart your journey into the world of biotech entrepreneurship? NCI SBIR is excited to announce the launch of the SBIR/STTR Training and Entrepreneurship Program (STEP) to help innovators working to bring their projects from lab to market.

This new program provides FREE entrepreneurship training and Phase I SBIR/STTR application preparation support to small businesses working to commercialize cancer technologies. Over the course of 16 weeks, participants will:

• Enhance their understanding of customer discovery
• Learn grant writing techniques to develop more competitive funding applications
• Expand their knowledge of the SBIR/STTR application process

The STEP application portal is accepting applications until Friday, November 1, 2024. The program is open to innovators interested in submitting an application toward the April 2025 SBIR/STTR funding cycle and who have not won an SBIR/STTR award from NIH in the last 10 years.

Register for the webinar

FDA clarifies cGMP expectations for investigational drugs

The FDA does not expect drugmakers to fully conform with current good manufacturing practice standards and have a finalized commercial manufacturing process until investigational products are in Phase 2 studies, but small businesses developing new drugs should familiarize themselves with FDA guidance and International Council for Harmonization standards, says Paresma Patel of the FDA's Office of Product Quality Assessment. "When it comes to understanding how much of your manufacturing process should actually be conducted under cGMP, what we recommend is sponsors come in and have a CMC-focused meeting to discuss their manufacturing process to support pivotal clinical studies and ultimately, commercialization," Patel said.

Full Story: Regulatory Focus (9/6)  

BioFutures 2025 will be publishing in March! If you are interested in advertising opportunities, please contact us at info@ihif.org.

Topics to include:

• Obesity/Weight management/metabolic disease
• Neurosciences
• Start-up Round-up
• Thought Leader Op-Ed's
• Legislator of the Year feature
• and more!

FDA recommends use of routine clinical practice data for drug trials

The FDA has released a draft guidance recommending the use of data from routine clinical practice, usually collected during regular health care visits, in clinical trials to support drug approvals. "Advances in information technology and widespread use of electronic health records (EHRs) have facilitated access to real-world data obtained during routine clinical care and provided new opportunities for the integration of clinical research and clinical care," the agency said.

Full Story: Regulatory Focus (9/19)  

With BIO Business Solutions (BBS), IHIF members are eligible for discounts and savings on a wide variety of products and services geared towards life sciences companies and general business needs. From lab supplies, waste removal and insurance, to office supplies and credit cards, there is something here for every company. Explore your options and enjoy the benefits of being an IHIF member!

Featured Program

Please share this with someone in your company who would find this helpful

BIO Business Solutions provides cost-savings offers to eligible IHIF Members. To learn more about the programs and services available, please click here. Not an IHIF member? Join today!

IHIF Membership

Be sure to check out the new IHIF Member Directory featuring company descriptions and an alphabetical listing.

Welcome New IHIF Members!

We’re building the most patient-friendly way to access clinical trials. Our team @ Power believes that every patient deserves the chance to participate in a life changing clinical trial. Directory Link

Continuity Pharma is a spin-out from the lab of Prof. David H. Thompson at Purdue University. We leverage innovative chemistry and flow technology to improve quality, safety and sustainability in the pharmaceutical industry by developing advanced manufacturing processes for small molecule active pharmaceutical ingredients (API). Using our technology, our customers can drive down costs, and bring high-quality products to market faster and cheaper. Directory Link

At EchoTech, we've developed a comprehensive autonomous vision platform. Our initial product, Magic Mode, is designed to enhance the lives of powered wheelchair users. We believe everyone deserves the freedom and confidence to explore their surroundings without limitations, and that's precisely what Magic Mode delivers. Directory Link

HabitHalo was founded by a former vaper who struggled with control and realized existing methods needed to be updated and made specifically for vapers. HabitHalo is the result of this collective dedication, packaged conveniently in an app that personalizes to each vaper and automates restrictions through our vape compatible hardware device. Directory Link

EIG's mission is to develop highly accurate and non-invasive multi-omic molecular testing solutions for complex diseases like cancer. The company has developed a Multi-omic Integration Platform that combines detection of DNA, RNA, protein and metabolite targets into a single assay. This breakthrough approach transforms the field of molecular diagnostics by offering unparalleled accuracy with comprehensive insights for early disease detection. Directory Link

ScyTek Biotech Life Sciences manufactures diagnostic reagents, special stains, antibodies, hematology, immunohistochemistry, buffers, microbiology, hematoxlyn, etc. Directory Link

Simplicity. Flexibility. Scalability.

We aim to help innovators move faster getting their medical devices to market. Building lean systems and processes along the way to support changing needs and markets. We want to embed ourselves in your business to support long term goals and help grow your team's skills. Directory Link

Krauter Cleanrooms is an Indianapolis based design build company specializing in cost effective modular construction. From controlled lab space to ISO and USP rated facilities. Krauter Cleanrooms is a one stop local source that delivers: Consulting / Design services, Sales / Technical / Engineering Support, Expert Installation, Partnerships with Sub-Trades and Suppliers for turn-key solutions Directory Link

Helmer Scientific provides medical-grade, temperature controlled storage and processing solutions and services for pharmacy, blood bank, laboratory and research. Directory Link

Cushman & Wakefield is a leading global real estate services firm that helps clients transform the way people work, shop and live. It has some 45,000 employees in more than 70 countries.

Our life sciences real estate experts drive customized, dynamic solutions for investors, owners, developers and occupiers within the quickly evolving life sciences sector. Directory Link

Output Medical designs FDA registered medical devices that automate urine output measurements for critically ill patients at high risk of decreased kidney function. We initially target patients with substance use dependency who present with a drug overdose in acute care settings. The current standards rely upon manual methods of urine output measurement which are inaccurate, time consuming, and cannot trend the urine output – all of which adversely affect the quality of patient care. Directory Link

Element is a global Testing Inspection and Certification (TIC) company headquartered in London. It specialises in materials testing and provision of certification schemes in building material, aerospace, transportation, health sciences, oil and gas, and fire protection. Directory Link

PragmaClin is developing digital approaches to managing Parkinson's Disease. PragmaClin aims to help patients with Parkinson's Disease monitor their condition with the use of our flagship software, PRIMS. We want a world where patients can get help faster, with more accurate results. Directory Link

Grannus is an early-stage oncology drug development company, with a unique approach to a well-validated target, the chaperone protein Hsp90, that has demonstrated efficacy in clinical studies but known limitations that have prevented previous drugs from being approved. By selectively targeting individual isoforms, or versions, of Hsp90, Grannus has overcome the limitations of the previous failed programs, and unlocked opportunity across multiple tumor types as a single therapy and in combination with other approved drugs. Directory Link

Our global team designs, manufactures and markets effective, innovative solutions that support orthopedic surgeons and clinicians in restoring mobility, alleviating pain and improving the quality of life for patients around the world. Directory Link

As a member benefit, IHIF is pleased to share and highlight member company news! Please send press releases to info@ihif.org.

MBX Biosciences shares jump 48% in Nasdaq debut

Carmel-based MBX Biosciences Inc. saw it shares jump nearly 48% in its debut on the Nasdaq. The five-year-old company is developing treatments for endocrine and metabolic disorders, such as hypoparathyroidism, post-bariatric hypoglycemia and obesity. 

More

Life Sciences Update is Now Available

Stay informed: Key industry trends and market insights

The first half of 2024 was a dynamic period for the life sciences industry! We saw the return of the $1 billion funding round, a surge in IPO activity, exciting M&A announcements, and increased FDA biological approvals. However, commercial real estate in the life sciences sector experienced a slower pace, with subdued leasing activity, rising vacancies, and softer asking rents in some markets.

As we look ahead, anticipated interest rate cuts in the second half of 2024 are expected to reignite activity, setting the stage for growth through the end of the year and into 2025.

Discover More

Market Summaries

IU, Indiana Biosciences Research Institute partner on new personalized medicine center

Indiana University is teaming up with Indiana Biosciences Research Institute to create what they are calling a “joint center of excellence” to develop better personalized care for patients with diabetes, cancer, Alzheimer’s disease and pediatric rare disease. The two institutions said in a joint statement Wednesday the operation will be called The Joint Center of Excellence for Point of Care Precision Medicine. 

More

Copying viruses? It works, researchers delivering novel therapies to bladder cancer cells

Purdue researchers led by professor David Thompson are copying viruses to mimic their dual-layer structure to deliver treatment to targeted cancer cells. The Purdue Innovates OTC has applied for patents to protect the life-saving IP.

Learn More

Bristol Myers Squibb (BMS) received FDA approval for COBENFY™ (xanomeline and trospium chloride), an oral medication for the treatment of schizophrenia in adults.

COBENFY represents the first new class of medicine in several decades and introduces a fundamentally new approach to treating schizophrenia. It is expected to be available to patients in the United States in mid-October 2024. BMS also announced the launch of COBENFY Cares™, a program designed to support patients who have been prescribed COBENFY.

Schizophrenia is a persistent and often disabling mental illness affecting how a person thinks, feels and behaves. It is estimated to impact approximately 2.8 million people in the United States. While the current standard of care can be effective in managing symptoms of schizophrenia, up to 60% of people experience inadequate improvement in symptoms or intolerable side effects during therapy.

The press release is available here

Notre Dame surpasses $1 billion in research funding proposals

The University of Notre Dame is touting new records when it comes to its research funding in the last fiscal year. The university says it submitted 1,310 proposals for external funding totaling just over $1 billion, the first time it has surpassed that mark. More

Just One Click Away: FDA QMSR Training has launched

FDA QMSR and ISO 13485 Requirements for Practitioners and Auditors

ISO 13485 and FDA QSR 21 CFR Part 820 Foundation for Practitioners and Auditors

For the first time ever, you can now upskill your knowledge Anytime, Anywhere on the FDA's Quality Regulations whether you want to understand the new Quality Management System Regulation (QMSR) that comes into full effect in February 2026 or the current Quality System Regulation (QSR 21 CFR Part 820).

Our eLearning is a proven method trusted by a growing list of Competent Authorities, Notified Bodies & many of the largest Medical Device Manufacturers in the world.

Learn More

Sanofi, RadioMedix, and Orano Med announce licensing agreement on next-generation radioligand medicine for rare cancers

As part of its effort to develop innovative treatments for people living with rare cancers, Sanofi has entered into an exclusive licensing agreement with RadioMedix, Inc., a US clinical-stage biotechnology company developing radiopharmaceuticals for PET imaging and targeted alpha therapy (TAT) against unmet medical needs in cancer, and Orano Med, a French clinical-stage biotechnology company, subsidiary of the Orano Group, developing lead-212 (212Pb) radioligand therapies (RLTs) against cancer.

This collaboration between Sanofi, RadioMedix and Orano Med focuses specifically on the late-stage project, AlphaMedixTM (212Pb-DOTAMTATE), which currently is being evaluated for the treatment of adult patients with unresectable or metastatic, progressive somatostatin-receptor expressing neuroendocrine tumors (NETs), a rare cancer. AlphaMedixTM is a TAT which consists of a somatostatin receptor-targeting peptide complex radiolabeled with lead-212 (212Pb) that serves as an in vivo generator of alpha particles.

Read More

Indiana Awarded $550K in Grant Funding to Power Small Business Exports

Hoosier entrepreneurs, small business owners encouraged to leverage IN-STEP program to market, sell Indiana-made products to international markets

The Indiana Economic Development Corporation (IEDC) secured $550,000 in competitive grant funding from the U.S. Small Business Administration (SBA) to support the export activities of Hoosier small businesses through the Indiana State Trade and Export Promotion (IN-STEP) grant program. IN-STEP, which launched in 2020, helps Indiana small businesses develop and expand export-related activities, opening up new international markets for Hoosier-made goods around the world.

Read More 

What We're Following at Home and on the Hill

• Find your legislators and keep up with IHIF's advocacy efforts - here
• Policy Forum Members: Session Updates and Bill Tracker (2024 Session)

IHIF Actions:

• Continued urging the reauthorization of the FDA Pediatric Rare Disease Priority Review Voucher (PRV) program
• Outreach to Senator Braun with concern about threats to IP protection
• Click here to see all of the topics and issues IHIF is monitoring

Q&A with NSCEB Chair Sen. Todd Young

Senator Todd Young, R-Ind., Chair of the National Security Commission on Emerging Biotechnology, is focused on advancing key biotech policies, particularly the Pasteur and Biosecure acts. "We must promote, protect, and prioritize the American biotechnology industry in the interest of maintaining a strong industry and global leadership and in the interest of our national security," Young said. BIO has been supportive of the advancement of these legislative efforts to enhance national security and public health.

Full Story: Bio News (9/27)  

G2G’s Summary Report on the 2024 Military Health System Research Symposium (MHSRS) is now ready.

This report features G2G’s conference takeaways and highlights from our meetings with Defense Health leadership and program managers. This is essential reading for innovators in MedTech, pharma, bioscience and healthcare who are interested in working in the military health space, but not sure where to begin. You can access the report here!

Separately, for those working in the medical countermeasures (MCMs) space who are interested in engaging with the Biomedical Advanced Research and Development Authority (BARDA), the agency has just announced that its 2024 Innovation Symposium will be held on November 6^th in Washington DC. Some key points:

• The symposium will bring together BARDA-supported innovators, other U.S. government partners, investors, and interested organizations to showcase, network, and form partnerships.
• The symposium will showcase early-stage health security innovations including through DRIVe, BARDA Ventures, Blue Knight, and CARB-X
• Opportunities are available to apply for presentation slots to showcase how your innovation can impact BARDA's mission.
• More information, including about registration can be found here

(Shared from our partners at G2G Consulting)

• G2G Consulting Monthly Non-Dilutive Gov't Funding Webinar - October 17 (noon) Register



• Purdue Life Sciences and Pharma Career Fair - October 10 - Learn More

• BioCrossroads Indiana Life Sciences Summit - November 7 - More

Thursday, October 24, 2024

(Please Note Date Change)

11:30 am - 1:00 pm

Location: Barnes & Thornburg LLP

11 S. Meridian Street, Indianapolis, IN 46204

The Indiana Life Sciences Association at 30

A Fireside Chat With President and CEO Kristin Jones

Celebrating 30 years this year by ushering in a new name and branding, the Indiana Life Sciences Association (formerly known as the Indiana Health Industry Forum) will continue its dedication to the industry. Its leadership will not change – since 2010, Kristin Jones has steered the association with a steady hand, never losing sight of its constituency, and always looking for ways to increase and enhance member benefits and advocacy efforts, thereby growing the life sciences industry as a whole.

Kristin’s efforts to grow the industry in Indiana have borne fruit, stretching beyond state and even international borders. Please join us for this special October Life Sciences Lifeline, as we sit down with Kristin to ask her about where the organization has been, what she envisions for the future, and what the biggest challenges are to the industry in Indiana.

If you are a member, or considering membership, do not miss out on this opportunity to hear directly from one of our foremost leaders in the life sciences industry in Indiana.

There will not be a Zoom option for this session.

• Welcome/Moderator – Deborah Pollack-Milgate, Partner, Barnes & Thornburg
• Guest - Kristin Jones, President and CEO, IN Life Sciences Association

There is no charge to participate.

FDA Webinars

October 9, 2024 ICH M12 Drug-Drug Interaction Studies Final Guidance

• This webinar will discuss the ICH M12 Drug Interaction Studies guidance which is the first globally harmonized regulatory guidance on assessments of pharmacokinetic drug interactions mediated by metabolic enzymes and drug transporters. The guidance describes a systemic approach to evaluation of the drug interaction potential of investigational drugs during drug development and regulatory review.

October 16, 2024 Global IDMP Implementation - Getting Closer to the Goal

• Attend this webinar to learn how Identification of Medicinal Products (IDMP) offers a global framework for the unique identification and consistent documentation of medicinal products, facilitating effective information exchange among regulators, manufacturers, suppliers, and distributors. Once fully adopted, these standards will enhance pharmacovigilance, address drug shortages, and improve medication safety worldwide.

Join the world’s top medtech executives at the leading medical technology event.

IHIF Members Use Promo Code for a 10% Discount MEDTECHCONSPOJOINUS10

The MedTech Conference in Toronto, Canada, October 15-17, 2024, will help you look ahead and create new possibilities. Featuring world-class speakers, a cross-cutting educational program, invaluable networking and next-level technology, this forum for transformational ideas is a can’t-miss event for the industry’s prominent and most promising companies.

Medtech's momentum is transforming health care, making this the perfect moment to join the global medtech community in Toronto at The MedTech Conference. With advancements in technology, increased investment, and a global focus on innovation, medtech is now leading the charge in shaping the future of health care.

Our industry is making rapid strides in AI, robotics, wearable devices, telemedicine, and personalized medicine—innovations that are enhancing patient care and making health care more accessible. As we stand at the forefront of these changes, there’s no better time to be part of this transformation.

Learn More